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Trial registered on ANZCTR
Registration number
ACTRN12617000835347
Ethics application status
Approved
Date submitted
31/05/2017
Date registered
7/06/2017
Date last updated
30/07/2019
Date data sharing statement initially provided
30/07/2019
Date results provided
30/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Changes in movement quality and physical performance in response to an 8 week individualised movement quality assessment informed exercise intervention in apparently healthy adults: A randomised trial.
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Scientific title
The changes in movement quality and measures of physical performance in healthy active adults (28-55 y) in response to an 8 week individualized movement quality assessment driven exercise intervention, in comparison to an 8 week traditional resistance training regime.
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Secondary ID [1]
291858
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None
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Universal Trial Number (UTN)
U1111-1196-2999
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Movement Quality
303131
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Physical Performance
303132
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Condition category
Condition code
Physical Medicine / Rehabilitation
302583
302583
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants within the intervention group will undertake an 8 week individualized exercise regime to improve strength and quality of movement, which will be based upon the results of their individual movement quality assessment outcome score. The exercise intervention will be based around the results of their movement quality assessment, and will be targeting improvements in movement quality. Exercise selection and progression will be determined at the discretion of the trainers providing the intervention based upon their movement quality assessment results.
The Movement quality assessment will involve the evaluation of 9 movements that occur commonly in gym settings, and allow the identification of movement dysfunction and potential muscular imbalances. These movements include the following: a bilateral squat; a forward lunge; a dead-lift with a bent over row; a single leg squat; an overhead reach; a seated thoracic rotation; a 4 point hold with opposite arm and leg lifts (also known as a bird dog); a push up; and an active straight leg raise test. Poor performance on any one (or more) of these test will identify areas of muscular imbalance or dysfunction that will be used to guide subsequent exercise prescription.
The control group will undertake an 8 week traditional resistance training exercise regime to improve strength and aerobic fitness. The trainers providing the training regime to the control group will not have access to their movement quality assessment information, and will not be targeting improvements in movement quality.
Each exercise regime will consist of 2 sessions per week, lasting 60 minutes each session, for a total time commitment of 16 hours per participant over 8 weeks. Every session, for both the intervention and control group, will be one-on-one with a trainer. These sessions will be performed at The University of South Australia's City East Campus Gym facility.
The training performed on both the control and intervention group will be made progressively more challenging by incorporating the principle of progressive overload (increments of 2-10% weekly). All training will be supervised by accredited exercise trainers. The sessions will be performed at a moderate to vigorous intensity, with sessional RPE being obtained at the end of each session.
All sessions will be recorded to provide information on the exercises performed each session, with the loads used for those exercises. The programs will be structured in accordance the ACSM guidelines for exercise prescription, in which each core muscle group will be trained for 3 sets of 8-12 repetitions per session.
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Intervention code [1]
297975
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Treatment: Other
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Comparator / control treatment
This study will use a traditional resistance training regime (based upon the principals of the ACSM guidelines for exercise prescription) as the control group. This group will not receive any information from their baseline movement quality assessment.
Based upon these recommendations, each individual in the control group will be performing resistance training using a full body training program, 2 times per week. Each major muscle group of the body (eg. legs, shoulders, chest, back, abdomen, and hips) will be trained each session. There will be at least 48 hours between each session (eg. Monday and Wednesday, Monday and Thursday, Tuesday, and Thursday, Tuesday and Friday, Wednesday and Friday). Compound movements using free weights will be prioritized over machine based and isolation exercises. Exercise progression and selection within this framework will be up to the discretion of the trainers.
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Control group
Active
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Outcomes
Primary outcome [1]
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Changes in movement quality as assessed by the movement quality assessment tool MovementSCREEN PRO 'Trademark' (score range from 0-100 points, measured as a percentage)
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Assessment method [1]
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Timepoint [1]
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Baseline and Post intervention (at the completion of the 8 week training period).
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Secondary outcome [1]
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3 repetition maximum trap bar deadlift (measured in kilograms)
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Assessment method [1]
334495
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Timepoint [1]
334495
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Baseline and Post intervention (at the completion of the 8 week training period).
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Secondary outcome [2]
334635
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3 repetition maximum high bench row (measured in kilograms)
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Assessment method [2]
334635
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Timepoint [2]
334635
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Baseline and Post intervention (at the completion of the 8 week training period).
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Secondary outcome [3]
334636
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3 repetition maximum bench press (measured in kilograms)
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Assessment method [3]
334636
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Timepoint [3]
334636
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Baseline and Post intervention (at the completion of the 8 week training period).
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Secondary outcome [4]
334637
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Single leg hop distance (measured in centimetres)
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Assessment method [4]
334637
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Timepoint [4]
334637
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Baseline and Post intervention (at the completion of the 8 week training period).
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Secondary outcome [5]
334638
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vertical jump height (measured in centimeters)
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Assessment method [5]
334638
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Timepoint [5]
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Baseline and Post intervention (at the completion of the 8 week training period).
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Secondary outcome [6]
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broad jump distance (measured in centimeters)
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Assessment method [6]
334639
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Timepoint [6]
334639
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Baseline and Post intervention (at the completion of the 8 week training period).
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Secondary outcome [7]
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Maximal oxygen uptake as estimated by the Chester step test (reported in ml/kg/min)
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Assessment method [7]
335288
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Timepoint [7]
335288
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Baseline and post intervention (at the completion of the 8 week training period)
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Secondary outcome [8]
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Functional Movement Screen (FMS)
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Assessment method [8]
350795
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Timepoint [8]
350795
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Baseline and post intervention (at the completion of the 8 week training period)
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Secondary outcome [9]
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sRPE (borgs CR10 scale) will also be obtained at the completion of each training session.
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Assessment method [9]
350796
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Timepoint [9]
350796
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This outcome measure is more exploratory, and was completed at the completion of each training session by every single participant. As there were 16 sessions, this was obtained 16 times.
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Eligibility
Key inclusion criteria
People will be eligible for participation if they are considered low risk in accordance with the Exercise and Sports Science Australia (ESSA) adult pre-exercise screening tool. Participants will be excluded if they have any barriers restricting their ability to perform vigorous physical activity, such as pre-existing injury or inadequate time to commit to the intervention.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Are classified as moderate or high risk in accordance with the Exercise and Sports Science Australia (ESSA) adult pre-exercise screening tool.
Have barriers restricting their ability to perform vigorous physical activity, such as pre-existing injury or inadequate time to commit to the intervention.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will not be made aware as to whether they have been placed in the intervention or control group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into one of the two groups using minimisation to balance the groups for age, gender, and current exercise training status. Randomisation and allocation to treatment will be performed by an investigator in a separate building who is not involved in the intervention, data collection or statistical analysis. The primary outcome measure will be undertaken by an independent researcher. The secondary outcomes will be undertaken by the lead investigator due to funding and resource constraints.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Groups will be balanced for age, gender, and current exercise training status.
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Treatment effectiveness analysis will be blinded and by intention-to-treat. Continuous data will be explored for normality to satisfy assumptions for parametric statistical analyses. The differences
between groups for primary and secondary outcomes will be assessed using a linear mixed effects model, with intervention group, time and the interaction between these two entered as independent variables. In case of significant missing data, sensitivity analysis will be conducted using imputation where reasonable. A secondary analysis will be conducted to assess the influence of training adherence (as measured by attendance and session completion) on training outcomes. Effect sizes and 95% confidence intervals for the primary and secondary outcomes will also be presented. The level of significance for analyses will be set at p <0.05. Statistical analyses will be performed using Stata software (v14, Statacorp, TX).
A set of pre-specified analyses to investigate potential mechanisms for changes in movement quality and physical performance will be performed. Univariate correlations and separate multiple regression models will be used to explore the relationship between the baseline scores and changes in movement quality as measured by MovementSCREEN (independent variable) and changes in physical performance (dependent variables). Standard assumptions and checks for regression will be followed for all analyses, which will be conducted in STATA (Statacorp, TX, USA).
A total of 60 participants (30 per group) will provide 80% power to detect a difference at a two-sided 0.05 significance level, of 0.8 times the standard deviation, allowing for 13% dropout. There are no pre-existing data on intervention effect sizes from movement quality training specific to that being tested in this study. Therefore, the calculation was performed considering the best available intervention effect size from previous research (Bodden et al 2015), and we have conservatively taken a smaller effect size for this trial.
Recruitment
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
12/06/2017
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Actual
19/06/2017
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Date of last participant enrolment
Anticipated
1/11/2018
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Actual
18/10/2018
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Date of last data collection
Anticipated
28/12/2018
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Actual
9/01/2019
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Sample size
Target
60
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment postcode(s) [1]
15900
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5001 - Adelaide
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Recruitment postcode(s) [2]
15901
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
296357
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University
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Name [1]
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University of South Australia
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Address [1]
296357
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University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia.
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Country [1]
296357
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Australia
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Funding source category [2]
296358
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Commercial sector/Industry
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Name [2]
296358
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Corrective Exercise Australia
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Address [2]
296358
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Corrective Exercise Australia
9 Kensington Rd
Norwood SA 5067
Australia.
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Country [2]
296358
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Australia
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Primary sponsor type
University
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Name
University of South Australia
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Address
University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia.
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Country
Australia
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Secondary sponsor category [1]
295297
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Commercial sector/Industry
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Name [1]
295297
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Corrective Exercise Australia
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Address [1]
295297
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Corrective Exercise Australia
9 Kensington Rd
Norwood SA 5067
Australia
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Country [1]
295297
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297587
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University of South Australia's Human Research Ethics Committee
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Ethics committee address [1]
297587
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University of South Australia School of Health Sciences. GPO Box 2471 Adelaide SA 5001 Australia.
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Ethics committee country [1]
297587
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Australia
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Date submitted for ethics approval [1]
297587
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01/04/2017
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Approval date [1]
297587
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09/05/2017
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Ethics approval number [1]
297587
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0000036267
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Summary
Brief summary
Movement quality has been described as an individual’s ability to perform a specific movement pattern in an optimal manner. Poor movement quality is typified by the inability to perform basic, or ‘fundamental’, movement tasks in a balanced and well-coordinated manner, which is underpinned by a disruption to the way muscles normally move and support joints during these movement tasks. Poor movement quality has been shown to significantly alter the loading of individual joints, reduce an individual’s ability to express strength and power, and limit the ability to complete movement tasks effectively. Conversely, good movement quality has been said to allow the safe and effective loading of joints, subsequently improving performance capabilities. The assessment of movement quality is therefore said to provide an indication of muscular dysfunction. We suggest that this information can then be used to design an appropriate exercise intervention targeting improvements in that dysfunction, and therefore improvements in movement quality. The proposed research will look to see whether a specific training intervention can yield improvements in movement quality and physical performance, and whether those improvements occur to a greater degree in comparison to a more traditional resistance training program. To achieve these aims, healthy adults (18-55 y) will undergo 1 of 2 interventions, either 1) an individualized exercise intervention guided by a movement quality assessment, or 2) a standard resistance training program in accordance to the ACSM guidelines. Each training protocol will involve 2 60 minute training sessions per week, for a duration of 8 weeks. Primary (movement quality score) and secondary (physical performance measures) outcome measures will be recorded at baseline, and at the completion of the 8 week intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
74530
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Mr Hunter Bennett
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Address
74530
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University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia
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Country
74530
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Australia
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Phone
74530
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+61433377222
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Fax
74530
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Email
74530
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[email protected]
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Contact person for public queries
Name
74531
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Hunter Bennett
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Address
74531
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University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia
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Country
74531
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Australia
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Phone
74531
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+61433377222
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Fax
74531
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Email
74531
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[email protected]
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Contact person for scientific queries
Name
74532
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Hunter Bennett
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Address
74532
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University of South Australia
School of Health Sciences.
GPO Box 2471
Adelaide SA 5001
Australia
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Country
74532
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Australia
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Phone
74532
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+61433377222
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Fax
74532
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Email
74532
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
To retain participant anonymity.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
3506
Informed consent form
372868-(Uploaded-29-07-2019-12-51-15)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF